Yogabased Movements Weekly (Online Live or Face to Face) for Primary Headaches
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Headache diary - frequency of headaches
研究概览
简要总结
Brief Summary:
Migraine and/or Cluster Headache: Study Overview
**Background:** Migraine and cluster headache are two primary headache disorders that significantly impact quality of life and functionality in those affected. According to the WHO's recurring burden of disease reports, migraine is among the neurological conditions responsible for the highest number of years lost due to illness. The headaches associated with migraine and cluster headache range from moderate to severe and cause great suffering. Available treatments do not work for everyone and are often associated with adverse side effects. Physical activity has been shown in several studies to have a positive effect on headache. Given the high prevalence of mental health issues, stress, and sleep problems within this patient group, relaxation and low-intensity exercise such as yoga-based movements (YB) could potentially help individuals improve sleep and well-being, while also providing some preventive effect on headaches.
**Hypothesis:**
Individuals with severe migraine or cluster headache have a strong need for new treatment options. Alternative therapies such as yoga-based exercises, when combined with standard medical treatment as per clinical guidelines, may positively impact:
Headache symptoms, Sleep quality and Overall life quality
- Purpose and Goals:** This randomized controlled study aims to evaluate the effect of a web-based yoga (YB) or live face to face (FTF) intervention in individuals suffering of primary headaches-mainly chronic migraine and/or cluster headache. The study will assess the effect of YB on health-related changes in headache frequency, intensity, and duration associated with primary headache conditions, with a focus headache frequency. A secondary objective is to analyze quality of life, sleep quality, mental health as depression and anxiety. The RCT will also measure objective sleep and biomarkers. We are now summarizing the effects after a pilot study.
- Relevance for the Patient Group:** The core objective of the project is to determine whether yoga-based exercises can serve as a complementary treatment to enhance quality of life and health in patients with severe primary headache. To ensure equal healthcare access, this intervention will be delivered in digital format and/or FTF to optimize availability and expand care for individuals with primary headache disorders. These efforts aim to improve life quality and well-being in a vulnerable patient population. Headache conditions often affect individuals in their most productive years, and many live with symptoms for decades. Both work and private life are frequently disrupted, resulting in sick leave and social isolation. Close relatives are also affected, as those suffering from headaches require more recovery time to cope with daily life. With this proposed project, we aim to use physical yoga, rooted in holistic traditional medicine, to help individuals with severe primary headache achieve better physical and mental health-particularly improved sleep quality, which in turn enhances overall life quality.
详细描述
Detailed Description:
Current Situation
Migraine and cluster headache are two neurological conditions characterized by recurrent attacks of severe headache. Approximately 14% of the population is estimated to suffer from migraines, while cluster headaches have a prevalence of around 0.1%. The phenotype is marked by unilateral headache attacks lasting approximately 15 minutes to three hours for cluster headache and three hours to three days for migraine. Acute treatment for migraines and cluster headaches typically involves triptans or oxygen therapy to break the attacks, and prophylactic treatment when needed.
Studies have shown that individuals with headaches experience significant impacts on quality of life and often suffer from mental health issues. Research from Karolinska Institutet and the Headache Centre in Copenhagen has demonstrated sleep disturbances among individuals with cluster headaches. Sleep-related diagnoses are also frequently reported in individuals with migraine, and migraine is more prevalent among shift workers compared to non-shift workers. Collectively, these studies indicate a strong connection between sleep problems, mental health, and headache.
The disease burden in high-frequency migraine, chronic migraine, and cluster headache is substantial, and additional alternative treatments are needed alongside standard pharmaceutical therapies. Individuals with these headache types report higher sick leave rates than the general population, and cluster headache sufferers with concurrent mental health issues show increased prevalence for long-term sick leave and disability pension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed chronic migraine and/or cluster (Hortons) headache
- •Men and women 18-65 years
- •Diagnosed with chronic/high frequency migraine (≥15 headache days/month with at least ≥8 with migraine)
- •Diagnosed with chronic cluster head ache (i.e shorter remission than 3 months per year), diagnosed according to ICHD-III criteria.
- •Ability to perform yoga based moments and to give consent.
- •Internet connection with computer/ipad/mobile to perform digitally/tele-health instructions
- •Willing to use wristwatch for actigraphy
- •Willing to leave blood samples in laboratory
排除标准
- •Recent or planned operations during the last 6 weeks
- •Drug dependence, alcohol dependence, mental disorders as psychosis, bipolar disorder, anxiety as PTSD etc)
- •Parallel enrollment in other clinical trails
- •Unmedicated high blood pressure, heart disease as heart failure
- •Non Swedish speaking
- •Not able to perform low intensity exercise at home or FTF (face to face) - both online or live.
- •Participants unsure to participate due to drug addiction or other causes
- •Disorientation and not able to inform regarding other serious conditions
研究组 & 干预措施
No intervention - waiting list
Intervention yogic exercises
Yogabased movements (online live or face to face) for primary headaches
干预措施: Intervention yoga based exercises (Other)
结局指标
主要结局
Headache diary - frequency of headaches
时间窗: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Headache frequency (number of days a month and number of attacks per day)
Sleep quality using insomnia severity scale (ISI)
时间窗: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Primary Outcome Measure: Sleep quality using insomnia severity scale (ISI) \[Time Frame: Baseline and 8-12 weeks after the end of the intervention, follow-up up to 24 weeks\] Total score from 0-28 - a score of 0-7 no clinical insomnia, 8-14 no insomnia, 15-21 clinical insomnia moderate, 22-28 clinical insomnia severe
Quality of life - headache intensity scale (HIT-6)
时间窗: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Total score between 36-78, low scores indicates high quality of life
Dysfunctional Beliefs and attitudes about sleep (DBAS-10)
时间窗: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Measures sleep related cognitions in a VAS (visual analog)-scale. The scale identifies specific, irrationell and affective thoughts that can disturb insomnia and evaluated sleep related cognitions. Factor I (5 items) was labeled Beliefs about the Immediate Negative Consequences of Insomnia. Factor II (3 items) was labeled Beliefs about the Long-term Negative Consequences on Insomnia. Factor III was labeled Beliefs about the Need for Control Over Insomnia (2 items). Administration time 10 minutes
Actrigraph - sleep quality
时间窗: Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks
Objective measurement of sleep using actigraphs worn on the wrist for one week at baseline and one week at the end of the study. ActTrust 2, Actiwatch or another brand is a wristwatch-like device that measures acceleration. By measuring acceleration at the wrist, an estimate of physical activity can be obtained, from which an activity pattern for a participant can be produced. This provides an objective measure of sleep duration and sleep quality. The sleep watch measures activity in general using tri-axial raw data accelerometer along with environmental light and temperature sensors and sleep is part of this through looking at reduced activity.
次要结局
- Actrigraph - sleep quality(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Quality of life - headache intensity scale (HIT-6)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Sleep quality using insomnia severity scale (ISI)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Dysfunctional Beliefs and attitudes about sleep (DBAS-10)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- The Migraine Disability Assessment Test (MIDAS)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Hospital Anxiety and Depression Scale (HADS)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Perceived stress scale (PSS-10)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Generalized Anxiety Disorder scale (GAD-7)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Nijmegen Dysfunctional breathing scale(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Interleukine 6 (IL-6)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Interleukin -1 (IL-1, especially IL-1β)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Adiponectin(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Brain-Derived Neurotrophic Factor -BDNF(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Melatonin (Urine, 6-sulphatoxymelatonin)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up up to 24 weeks)
- Headache diary - frequency of headaches(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Headache diary - intensity of headaches(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- Headache diary - duration of headaches(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
- C-reactive protein (CRP)(Baseline (day 1 of the study) and 8-12 weeks after the end of the intervention, follow-up for up to 24 weeks)
研究者
Marian Papp
Principal investigator, PhD
Karolinska Institutet